PRTC: resTORbio Notes Publication of Phase 2a Data

RNS Number : 3841U

PureTech Health PLC

12 July 2018

 

12 July 2018

PureTech Health plc

PureTech's resTORbio Publishes Results from Phase 2a Study in Journal Science Translational Medicine

Newly published data demonstrated significant reduction in incidence of all infections, including respiratory tract infections, in people aged 65 and older and improvement in immune function

PureTech Health plc (LSE: PRTC) ("PureTech Health"), a clinical-stage biopharmaceutical company developing novel medicines focused on the Brain-Immune-Gut (BIG) Axis, today notes that resTORbio, Inc. (NASDAQ: TORC), an affiliate of PureTech Health, has published the results from a Phase 2a study of its target of rapamycin complex 1 (TORC1) programme in a leading scientific journal, Science Translational Medicine. The newly published results from the Phase 2a study, which was completed prior to PureTech's founding of resTORbio, showed that inhibition of TORC1 with RTB101 alone or in combination with everolimus improved immune function and reduced the incidence of all infections, including respiratory tract infections (RTIs), in people aged 65 and older.  Respiratory tract infections are the 4^th leading cause of hospitalisation and the 7^th leading cause of death in people 65 years of age and over.

Topline results from resTORbio's Phase 2b study are expected in the third quarter of 2018 and will evaluate the effectiveness of RTB101 alone or in combination with everolimus in reducing the incidence of RTIs in elderly patients at increased risk of morbidity and mortality related to RTIs.

Joe Bolen, PhD, Chief Scientific Officer of PureTech Health, said: "These newly published results demonstrate the therapeutic potential and favourable safety profile of resTORbio's TORC1 programme as a potential new class of immunotherapy. When we co-founded resTORbio, these results, as well as data from other studies, were instrumental in our decision to advance RTB101 alone or in combination with everolimus into a Phase 2b clinical trial in respiratory tract infections, and we look forward to the results of that study."

The full text of the announcement from resTORbio is as follows:

resTORbio Announces Science Translational Medicine Publication of Phase 2a Data Showing Improvement in Immune Function and Decreased Infection Rates in People Aged 65 Years and Older

-      resTORbio's TORC1 inhibitors enhanced the function of the aging immune system and were associated with a statistically significant decrease in the incidence of all infections, including respiratory tract infections, in older people

-      Respiratory tract infections are the 4^th leading cause of hospitalisation and the 7^th leading cause of death in people 65 years of age and older

BOSTON, July 11, 2018 -- resTORbio (Nasdaq: TORC) today announced newly published data from a Phase 2a clinical trial demonstrating that target of rapamycin complex 1 (TORC1) inhibitor treatment improved immune function and decreased incidence of all infections, including respiratory tract infections (RTIs), in people aged 65 years and older. RTIs in particular are a significant health risk for the elderly with life-threatening consequences and few treatment options. Data were published in the July 11, 2018 online edition of the journal Science Translational Medicine.

"Inhibition of TORC1 has extended both lifespan and healthspan in multiple pre-clinical species," said Joan Mannick, MD, Co-Founder and Chief Medical Officer of resTORbio. "The results of this Phase 2a trial raise the possibility that TORC1 inhibition also has health benefits in older humans. In the Phase 2a trial, TORC1 inhibitor treatment was associated with a clinically meaningful reduction in the incidence of infections in people aged 65 years and older and an enhancement in the function of the aging immune system as assessed by influenza vaccination response and antiviral gene expression. The results need to be validated in additional clinical trials, but may have broad implications for the treatment of diseases of aging that we are actively investigating with our TORC1 inhibitor programme."

The data for this publication were gathered in a randomised, double-blinded, placebo-controlled Phase 2a study of 264 elderly volunteers at least 65 years of age without unstable medical conditions. Subjects were treated for 6 weeks with study drug and after a 2-week drug-free interval, were given a seasonal influenza vaccine. The incidence of infections was assessed for one year after initiation of study drug treatment. In the RTB101 monotherapy and RTB101+everolimus combination treatment arms, statistically significant and clinically meaningful reductions in the annual rate of infections of 33% (p=0.008) and 38% (p=0.001), respectively, compared to placebo, were observed. In addition, both RTB101 monotherapy and the RTB101+everolimus combination therapy were observed to reduce the incidence of RTIs at one year by 42% (p=0.006) and 36% (p=0.01), respectively. The combination of RTB101+everolimus was also observed to significantly enhance the response to influenza vaccination and upregulated the expression of critical antiviral genes that play a key role in enabling the immune system to protect the elderly from respiratory tract infections.

RTIs are the fourth leading cause of hospitalisations and the seventh leading cause of death in people aged 65 years and older in the United States. Moreover, the majority of RTIs in the elderly are caused by viruses for which there are currently no approved therapies. resTORbio's TORC1 inhibitor programme has the potential, if successfully developed and approved, to be a new class of immunotherapy that enhances the function of the aging immune system to fight infectious pathogens including viruses, and thereby reduce the incidence of respiratory tract infections.

Based on the results of the Phase 2a study, resTORbio is conducting a Phase 2b clinical trial to further investigate the potential benefits of RTB101 alone and in combination with everolimus in aging-related diseases. In the ongoing Phase 2b study, doses of RTB101 alone and in combination with everolimus are being evaluated as an immunotherapy to decrease the incidence of RTIs in older people at increased risk of morbidity and mortality from RTIs (defined as age 85 and older and age 65 and older with comorbidities). Dosing has been completed in the Phase 2b study and 16-week topline data is expected to be reported in the third quarter of 2018.

About RTB101

RTB101 is an oral, selective and potent inhibitor of target of rapamycin complex 1 (TORC1). RTB101 inhibits the phosphorylation of multiple targets downstream of TORC1. The combination of RTB101 with everolimus is synergistic and results in broader TORC1 inhibition. Inhibition of TORC1 has been observed to extend lifespan and healthspan in aging pre-clinical species and enhances immune, cardiac and neurologic function, suggesting potential benefits in several diseases of age.  

About resTORbio

resTORbio, Inc. is a clinical-stage biopharmaceutical company targeting TORC1 and other biological pathways that regulate aging to develop innovative medicines with the potential to extend healthy lifespan. resTORbio's lead programme is targeting the selective inhibition of TORC1, an evolutionarily conserved pathway that contributes to the decline in function of multiple organ systems, including the immune, cardiovascular and central nervous systems.

About PureTech Health

PureTech Health (PRTC.L) is an advanced, clinical-stage biopharmaceutical company developing novel medicines targeting serious diseases that result from dysfunctions in the nervous, immune, and gastrointestinal systems (brain-immune-gut or the "BIG" axis), which together represent the adaptive human systems. PureTech Health is at the forefront of understanding and addressing the biological processes and crosstalk associated with the BIG axis. By harnessing this emerging field of human biology, PureTech Health is pioneering new categories of medicine with the potential to have great impact on people with serious diseases. PureTech Health is advancing a rich pipeline of innovative therapies that includes two pivotal stage programmes, multiple human proof-of-concept studies and a number of early clinical and pre-clinical programmes. PureTech's research and development pipeline has been advanced in collaboration with some of the world's leading scientific experts, who along with PureTech's team of biopharma pioneers, entrepreneurs and seasoned Board, identify, invent, and clinically de-risk new medicines. With this experienced team pursuing cutting edge science, PureTech Health is building the biopharma company of the future focused on improving and extending the lives of people with serious disease. For more information, visit www.puretechhealth.com or connect with us on Twitter @puretechh.

Forward Looking Statement

This press release contains statements that are or may be forward-looking statements, including statements that relate to the company's future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

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